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YBB 6006-2012 English PDF (YBB6006-2012)

YBB 6006-2012 English PDF (YBB6006-2012)

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YBB 6006-2012: The Test Method for Residue of Solvent in Packaging Material

This method applies to the determination of residual solvents in pharmaceutical packaging materials. This method is based on the gas - solid balance. Take a certain area of the sample. Place into a sealed container. Under a certain temperature and time conditions, the organic solvent resided in the sample is heated and evaporated. After the equilibrium is reached, take headspace to quantitative inject into the gas chromatograph for analysis. Use the maintaining time to perform qualification. Use the peak area to perform quantitation. Determine according to the determination of residual organic solvents (Part 2, Chinese Pharmacopoeia 2010 edition).
YBB6006-2012
State Food and Drug Administration
of the PEOPLE Republic of China
Direct contact with drug?€?s
packaging materials and containers standard
National Institutes for Food and Drug Control
Packaging Materials and Pharmaceutical Excipients Inspection Institute
December 2012
The Test Method for Residue
of Solvent in Packaging Material
This method applies to the determination of residual solvents in pharmaceutical packaging materials.
This method is based on the gas - solid balance. Take a certain area of the sample. Place into a sealed container. Under a certain temperature and time conditions, the organic solvent resided in the sample is heated and evaporated. After the equilibrium is reached, take headspace to quantitative inject into the gas chromatograph for analysis. Use the maintaining time to perform qualification. Use the peak area to perform quantitation. Determine according to the determination of residual organic solvents (Appendix ??? P, Part 2, Chinese Pharmacopoeia 2010 edition).
Chromatographic conditions and system suitability test
Capillary column or other suitable columns that can satisfy the requirements of the test solvent separation may be selected.
Use the chromatographic-peak of the test substance to calculate. The number of theoretical plates is generally not less than 1000.
Unless otherwise specified, the same-type capillary columns with similar polarity can substitute each other. Number of theoretical plates: It must not be less than 5000. 1. Non-polar column: 100% dimethylpolysiloxane.
2. Polar column: Polyethylene glycol PEG-20M.
3. Medium-polar column: 6% cyanopropyl phenyl-94% dimethylpolysiloxane. 4. Low-polar column: 5% phenyl-95% methyl polysiloxane.
General selection:
Column: INNOWAX 0.32mm ?? 0.5??m ?? 60m
Detector: Flame ionization detector (FID)
Measurement conditions (for reference): Column temperature: Initial temperature is 50 ??C. Maintain for 5 minutes. Then rise the temperature at a rate of 10 ??C per minute TO 150 ??C. Inlet temperature is 200 ??C. The detector temperature is 220 ??C.
Split ratio: 10: 1
Nitrogen 2 ml / min; hydrogen 30ml / min; air 400ml / min
Separation: The separation BETWEEN the chromatographic-peak of the test substance AND its adjacent chromatographic-peak shall be greater than 1.5.
The relative standard deviation of the test substance?€?s peak area shall not exceed 10%.

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